Anaheim Clinical Trials (ACT), an adult and pediatric Phase I through Phase IV clinical research center with full-service CRO capabilities recently completed a 170 subject trial: 140 healthy volunteer subject trial plus 30 patients with psoriasis. The study was a multiple cohort design that included a healthy single ascending dose (SAD) with a 7-day inpatient stay with telemetry. After an interim data analysis, subjects then proceeded to the multiple dose (MAD) periods that included a 15-day stay. Another group of healthy subjects enrolled in the bioavailability cohort wherein subjects were admitted for 5 days for each of three dosing cycles with relation to food intake. Lastly, subjects with psoriasis participated in a very intensive 30-day stay that involved multiple procedures such as serial laboratory samples, skin biopsies and photography.
"This study was one of the most challenging studies we have done for the year since it involved multiple moving parts as well as very aggressive timelines,” said Dr. Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., ACT’s Medical Director. “Subject dedication and compliance, as well as the professionalism of our Clinical and Recruiting Teams were instrumental in completing this trial.”
According to Mark Gonzalez, Director, Patient Recruitment, "Finding subjects with psoriasis that have the corresponding body coverage for the study was challenging in itself, but finding those that can stay for 30 consecutive days is even more challenging! The Recruitment Team worked tirelessly to find these subjects, conducting night and weekend informational sessions, and reaching out to the community."
"This study was actually four (4) studies combined in one trial,” added Jeff de Leon, MD, PTRP, CPT1, Director, Phase I. “Principal Investigator involvement and availability was key in ensuring that subject safety and data integrity were upheld to the highest standards in this complex trial. Moreover, keeping an open line of communication with the Pharmaceutical Sponsor and CRAs, even during weekends and holidays, was integral to the success of the trial. And of course, the unwavering commitment of the team members involved made it possible to complete and meet aggressive enrollment timelines.”
About Anaheim Clinical Trials
Anaheim Clinical Trials (ACT) is an adult and pediatric Phase I clinical research center with full-service CRO capabilities, located in southern California (Anaheim). In addition to healthy volunteers, ACT has been particularly successful in enrolling special patient populations in complex trials and Japanese subjects for ethno-bridging trials. Our certified Principal Investigators have the expertise and interest in a wide variety of therapeutic areas, including GI, CNS, pain, metabolic/inflammation, infectious disease, and respiratory. ACT has been recognized by our customers for excellent quality research, timeliness, high patient enrollment, and ease of doing business.
Anaheim Clinical Trials Contact
Linda Gundaker, MBA, MT(ASCP)
Executive Vice President
Phone: (610) 937-2006
lgundaker@act-trials.com
"This study was one of the most challenging studies we have done for the year since it involved multiple moving parts as well as very aggressive timelines,” said Dr. Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., ACT’s Medical Director. “Subject dedication and compliance, as well as the professionalism of our Clinical and Recruiting Teams were instrumental in completing this trial.”
According to Mark Gonzalez, Director, Patient Recruitment, "Finding subjects with psoriasis that have the corresponding body coverage for the study was challenging in itself, but finding those that can stay for 30 consecutive days is even more challenging! The Recruitment Team worked tirelessly to find these subjects, conducting night and weekend informational sessions, and reaching out to the community."
"This study was actually four (4) studies combined in one trial,” added Jeff de Leon, MD, PTRP, CPT1, Director, Phase I. “Principal Investigator involvement and availability was key in ensuring that subject safety and data integrity were upheld to the highest standards in this complex trial. Moreover, keeping an open line of communication with the Pharmaceutical Sponsor and CRAs, even during weekends and holidays, was integral to the success of the trial. And of course, the unwavering commitment of the team members involved made it possible to complete and meet aggressive enrollment timelines.”
About Anaheim Clinical Trials
Anaheim Clinical Trials (ACT) is an adult and pediatric Phase I clinical research center with full-service CRO capabilities, located in southern California (Anaheim). In addition to healthy volunteers, ACT has been particularly successful in enrolling special patient populations in complex trials and Japanese subjects for ethno-bridging trials. Our certified Principal Investigators have the expertise and interest in a wide variety of therapeutic areas, including GI, CNS, pain, metabolic/inflammation, infectious disease, and respiratory. ACT has been recognized by our customers for excellent quality research, timeliness, high patient enrollment, and ease of doing business.
Anaheim Clinical Trials Contact
Linda Gundaker, MBA, MT(ASCP)
Executive Vice President
Phone: (610) 937-2006
lgundaker@act-trials.com
